Biotech Values

[DewDiligence]

Re: Speed of FDA’s Copaxone review

The following paragraph is from Teva’s Form 20-F filed with the SEC today (http://sec.gov/Archives/edgar/data/818686/000119312511036753/d20f.htm ):

Applications for FDA approval must contain information relating to bioequivalence (for generics), safety, toxicity and efficacy (for new drugs), product formulation, raw material suppliers, stability, manufacturing processes, packaging, labeling and quality control. FDA procedures generally require that commercial manufacturing equipment be used to produce test batches for FDA approval. The FDA also requires validation of manufacturing processes before a company may market new products. The FDA conducts pre-approval and post-approval reviews and plant inspections to implement these requirements. Generally the generic drug development and the ANDA review process can take three to five years.

In other words, the FDA’s review of NVS/MNTA’s Copaxone ANDA has, to date, not taken an unduly long time. This corroborates what Craig Wheeler said on MNTA’s 4Q10 CC (#msg-59783582):

I will now discuss M356, our generic version of Teva’s Copaxone, which we are developing in collaboration with Sandoz. The ANDA for this product was submitted in December 2007 and accepted for review in July 2008, so the FDA has been reviewing the ANDA for about two and a half years. Recently the FDA indicated that ANDA reviews are averaging 26 months, so given the complexity of this review, the pace of the review, while slower than we would like, is consistent with their current timeline. Our ANDA is under active review of the agency and we are doing all we can to ensure it moves as quickly as possible.